Non Small Cell Lung Carcinoma
Conditions
Keywords
Carcinoma, Non Small Cell Lung, EGFR mutation, Gefitinib
Brief summary
The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.
Interventions
DRUGGefitinib
Gefitinib tablet 250mg once daily orally
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma * Previously failed the first-line chemotherapy * Patient who can provide sample for EGFR mutation test
Exclusion criteria
* Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation * Any evidence of clinically active interstitial lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period of Progression-Free Survival | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | The median months without event of progression disease according to RECIST criteria is analysed. |
| Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0\ 4 scale (0=not at all to 4=very much). A possible score was 0\ 28. The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L. The percentage of patients who showed improvement is reported. |
| Overall Survival | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. | — |
| Adverse Event | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. |
Countries
South Korea
Participant flow
Recruitment details
From January 2007 to July 2008, 156 subjects were enrolled from 11 centers in Korea. First subject in date: 17 January 2007. Last subject last visit(Data cut off) date: 2 January 2009.
Pre-assignment details
The subjects were able to provide sample of EGFR mutation test and the subjects who had positive EGFR results or satisfy more than two condition of adenocarcinoma, female or non smoker were eligible.
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib gefitinib tablet 250 mg orally | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Gefitinib |
|---|---|
| Age, Customized < 65 years | 72 participants |
| Age, Customized >= 65 years | 66 participants |
| Disease Stage I | 1 Participants |
| Disease Stage III A | 4 Participants |
| Disease Stage III B | 20 Participants |
| Disease Stage IV | 113 Participants |
| EGFR mutation status Negative | 50 Participants |
| EGFR mutation status Positive | 59 Participants |
| EGFR mutation status Unknown | 29 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 18 Participants |
| Smoking history Ex-smoker | 17 Participants |
| Smoking history Never-smoker | 117 Participants |
| Smoking history Regular smoker | 4 Participants |
| Tumour history Adenocarcinoma | 121 Participants |
| Tumour history Other | 4 Participants |
| Tumour history Squamous carcinoma | 13 Participants |
| World Health Organisation (WHO) Performance Status 0 | 50 Participants |
| World Health Organisation (WHO) Performance Status 1 | 73 Participants |
| World Health Organisation (WHO) Performance Status 2 | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 141 / 154 |
| serious Total, serious adverse events | 25 / 154 |
Outcome results
Primary
Objective Response Rate(ORR)
Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Objective Response Rate(ORR) | 31.2 Percent of participants |
Secondary
Adverse Event
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Time frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Adverse Event | 141 participants |
Secondary
Overall Survival
Time frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.
Secondary
Period of Progression-Free Survival
The median months without event of progression disease according to RECIST criteria is analysed.
Time frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib | Period of Progression-Free Survival | 5.7 months |
Secondary
Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)
Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0\ 4 scale (0=not at all to 4=very much). A possible score was 0\ 28. The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L. The percentage of patients who showed improvement is reported.
Time frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) | 41 percentage of participants |